H-Guard Pilot Safety Evaluation in Haemodialysis Patients

NCT06070337 | Completed

• 1 other identifier: IH_001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to find out the safety and effectiveness of a new medical device called H-Guard. During this research study, participants will receive the standard of care haemodialysis treatment, as decided by the treating doctor. Participants will be observed during 5-6 haemodialysis treatments throughout the course of the study. The only change to the treatment process, will be the use of the medical device (H-Guard) to prime the dialysis system, before one of the treatments. Participants will have various blood tests taken throughout the course of the study for safety and research analysis.

Conditions

Renal Failure; Renal Insufficiency; Renal Disease

Keywords

Renal Failure; Haemodialysis; Renal; Kidney Failure; Dialysis

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] when using H-Guard as a Priming Solution

  Review of Adverse Events and Serious Adverse Event Frequency (All assessments)

  Assessed from date of consent until the end of the study (day 28)

Secondary Outcomes (8)

• Assess the Presence of AOT Antibody Analysis 7 days Post Intervention

  Assessed at visit 6 (day 14) [7 days after H-Guard intervention]

• Assess the Presence of AOT Antibody Analysis 14-21 days Post Intervention

  Assessed at visit 7 (day 21-28) [14-21 days after H-Guard intervention]

• Changes in Biomarker Analysis (Coag) Prior to and Post Intervention (platelet count)

  Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10)

• Changes in Biomarker Analysis (Coag) Prior to and Post Intervention (wbc count)

  Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10)

• Changes in Biomarker Analysis (Infl) Prior to and Post Intervention (CRP)

  Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10)

Other Outcomes (3)

• To Analyse Participants Blood Biomarkers at Baseline Compared With Post H-Guard Intervention

  Assessed at visits 2 (day 0), 4 (day 7) and 5 (day 10)

• Clinical Reported Endpoint Measure Analysis via Questionnaire

  Immediately Post Haemodialysis with H-Guard used as a priming solution (day 7)

• Clinical Reported Endpoint Measure Analysis via Questionnaire

  before, during and after H-Guard intervention (day 7) (visit 4)

Study Arms (1)

H-Guard

EXPERIMENTAL

Participants receiving H-Guard Intervention.

Device: H-Guard

Interventions

H-Guard DEVICE

A novel Haemodialyser primer used for one treatment only

H-Guard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 18 years and older at screening who have provided a signed and dated written informed consent
• Stable haemodialysis patients who are undergoing centre-based maintenance haemodialysis due to advanced kidney disease CKD stage 5, via arterio-venous fistula, graft or central venous catheter (i.e. with or without permanent vascular access)
• C3 deposition assay ratio ≤0.3 - measured immunologically using a C3 antibody in H-Guard vs human serum albumin coated ELISA plates
• Cytokine release assay - IL-6 concentrations following H-Guard vs Human Serum Albumin exposure must not exceed \>50% and absence of significant Human Serum Albumin stimulated reactivity
• Willing and able to attend and comply with study visits and study related activities

You may not qualify if:

• Patients requiring haemodialysis for acute kidney injury on critical care (ITU)
• Patients unable or unwilling to comply with all trial procedures, e.g. blood sampling
• Patients with a likely survival prognosis of less than 6 months
• Patients who have been admitted for any acute hospital-based treatments in the last 6 weeks
• Patients on any medication which may interfere with the analysis of the biomarkers
• Current or history of use of anti-thrombotic therapy less than 7 days prior to screening.
• Currently active malignancy
• Currently receiving radiation, immunotherapy or chemotherapy
• Patients with active infection or receiving antibiotics within 30 days prior to screening
• Currently enrolled or has been enrolled in the last 30 days in another investigational device or drug study
• Known allergy or hypersensitivity to any component of the study device and/or medication to be used during the study.
• Patients lacking capacity to provide informed consent
• Pregnant or breastfeeding women
• Women of child-bearing potential (WoCBP)\* who are unwilling to practice highly effective contraception\*\* or undergo pregnancy tests at screening and during the study\*\*\*
• Positive HIV and hepatitis B and C status, assessed from medical records only

Sponsors & Collaborators

• Invizius Limited: lead
• Tailored Clinical Research Solutions (TCRS): collaborator

Study Sites (1)

Manchester Royal Infirmary

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Leonard Ebah

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Magnus Nicolson

  Invizius Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, open label, pilot study of H-Guard® administered as a priming solution to both the blood tubing sets and dialyser of patients who are undergoing haemodialysis.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: October 6, 2023
• Study Start: October 19, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 7, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)